Systems, devices, and method for treating a sinus condition

ABSTRACT

Described here are systems, devices, and methods for delivery of an implant to a bodily cavity. The implant may include a hub and a plurality of legs, and may be moveable between a low-profile and expanded configuration. The systems may include a crimping device having a crimping member with a plurality of arms. The plurality of arms may engage the plurality of legs of the implant, and may move the legs to move the implant to the low-profile configuration. In some instances a delivery device may aid in crimping and/or delivery of the implant.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/210,078, filed on Mar. 13, 2014, which claims priority to U.S.Provisional Application Ser. No. 61/785,939, filed on Mar. 14, 2013, andtitled “SYSTEMS, DEVICES, AND METHOD FOR TREATING A SINUS CONDITION,”each of which is hereby incorporated by reference in its entirety.

FIELD

The invention is generally related to expandable implants, devices fordelivering and/or crimping implants, and methods of using them.

BACKGROUND

There is a movement toward using minimally-invasive approaches to treatconditions or diseases associated with bodily structures such as thenasal passageways, sinus cavities, or the like. For example, individualssuffering from nasal polyposis may have obstructed airways or sinusostia, and may experience symptoms such as difficulty breathing,headaches, sneezing, snoring, and general discomfort. Expandableimplants may be useful in maintaining, opening, or dilating bodilystructures such as nasal passageways, paranasal sinus cavities, or thelike. Given the variety of benefits that these devices may provide,additional expandable devices may be desirable, as well as systems forcrimping and/or delivering such implants.

BRIEF SUMMARY

Described here are devices, systems, and methods for treating one ormore sinus or nasal conditions. Also described here are devices andmethods for crimping an implant. In some variations, the devices maycomprise an expandable implant comprising a hub and plurality offilaments. The hub may comprise a plurality of apertures extendingthrough the hub, and each filament of the plurality of filaments may bepositioned in a corresponding aperture to extend through the hub. Inthese variations, placement of a filament in a corresponding aperturemay define a first leg on a first side of the hub and a second leg onthe second side of the hub. In some variations, the filament maycomprise a first straight segment, a second straight segment, and acurved segment positioned between the first straight segment and thesecond straight segment. In some of these variations, the curved segmentof each filament may be positioned in the corresponding aperture toposition the first straight segment on the first side of the hub and thesecond straight segment on the second side of the hub. In somevariations, each filament may be an extruded polymer filament. In somevariations, the hub and the plurality of filaments may be formed fromone or more biodegradable materials. In some variations, the implant maycomprise a drug-releasing coating. The implants described here may bedelivered to any suitable location, such as a sinus or nasal cavity. Insome variations, the methods described here may comprise advancing animplant to a location in a sinus cavity, sinus ostium, or nasalpassageway, delivering the implant, and expanding the implant from alow-profile configuration to an expanded configuration.

Described here are methods for crimping an implant. In some variations,the device may comprise a housing and a crimping member. The crimpingmember may comprise a plurality of arms radially extending from a stemportion, and the housing may comprise a recess, such that movement ofthe stem portion into the recess may rotate the plurality of armsrelative to the stem portion. In some variations, the recess maycomprise a central recess and a plurality of channels radially extendingfrom the central recess. In some of these variations, each arm of theplurality of arms may be at least partially positioned within acorresponding channel of the plurality of channels. In some variations,the device may further comprise a spring positioned between the stemportion and the recess. Additionally or alternatively, each arm of theplurality of arms may comprise at least one holder having a channel. Insome variations the stem portion may comprise a recess configured toreceive a portion of the implant.

Also described here are systems for treating a patient comprising animplant and a crimping device. The implant may comprise a plurality oflegs, and in some instances may further comprise a hub attaching theplurality of legs. The crimping device may comprise a crimping member,which may be configured to engage the plurality of legs and move theimplant to a low-profile configuration. In some instances, each leg ofan implant may be engaged by a correspond arm of a crimping member ofthe crimping device. The crimping member may be moved into a recess of ahousing of the crimping member to rotate the plurality of arms relativeto a stem portion of the crimping device. This rotation of the arms mayrotate the corresponding legs of the implant to move the implant to alow-profile configuration. In some variations, a delivery device may beused to push the crimping member into the recess of the housing. In someof these variations, a portion of the delivery device may be advanced tohold the implant in a low-profile configuration.

In some variations, a crimping device may comprise a housing, thehousing defining a crimping chamber having a proximal end and distalend, the crimping chamber having a proximal opening at the proximal endof the crimping chamber. The crimping device may further comprise aplurality of ribs located within the crimping chamber, wherein theplurality of ribs defines a plurality of channels between adjacent ribsof the plurality of ribs. The crimping chamber may comprise a firstsegment and a second segment, wherein the first segment extends from theproximal opening to a proximal end of the second segment. In some ofthese variations, the first segment may have an outer diameter whichtapers from a first diameter at a proximal end of the first segment to asecond diameter at a distal end of the first segment, wherein the firstdiameter is larger than the second diameter. In some of thesevariations, the second segment may have an outer diameter equal to thesecond diameter.

In some variations, the crimping chamber may further comprise a thirdsegment, wherein the second segment extends distally from a distal endof the second segment. In some of these variations, the third segmentmay have an outer diameter equal to an outer diameter of the secondsegment. Additionally or alternatively, the inner diameter of the secondsegment is equal to an outer diameter of the second segment.Additionally or alternatively, the third segment has an inner diametersmaller than an inner diameter of the second segment. In some variationsthe system may further comprise a delivery device having an inner shaftand an outer sheath. In some of these variations, an outer diameter of adistal end of the outer sheath may be less than or equal to the innerdiameter of the second segment and greater than the inner diameter ofthe third segment.

In some variations, the plurality of ribs and plurality of channelsextend at least partially through each of the first, second, and thirdsegments. In other variations, the plurality of ribs and the pluralityof channels may comprise a first plurality of ribs and a first pluralityof channels extending at least partially through first segment and asecond plurality of ribs extends and a second plurality of channelsextending at least partially along the third segment. In somevariations, the system may further comprise an implant, wherein theimplant comprises a hub and a plurality of legs extending from the huband wherein the implant is moveable from an expanded configuration to alow-profile configuration. The first segment and second segment may besized such that advancement of the hub from the first segment into thesecond segment crimps the implant from the expanded configuration to thelow-profile configuration. In some variations the crimping device mayfurther comprise a cap removably connected to the housing. In somevariations, the housing may further comprise a base.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an illustrative variation of the systems described here.

FIGS. 2A and 2B depict side views of a variation of the implantsdescribed here. FIGS. 2C and 2D depict side views of a hub and afilament, respectively, of the implant of FIGS. 2A and 2B. FIGS. 2E and2F show cross-sectional side views of the implant of FIGS. 2A and 2B.

FIGS. 3A and 3B depict side views of a distal portion of a deliverydevice as described here.

FIG. 4A depicts a perspective view of a portion of a variation of acrimping device described here. FIG. 4B depicts a cross-sectional sideview and FIGS. 4C and 4D depict perspective views of the crimping deviceof FIG. 4A. FIGS. 4E and 4F depict cross-sectional side views of thecrimping device of FIG. 4A in operation.

FIGS. 5A-5D depict perspective, top, side, and cut-away side views,respectively, of the a crimping device described here.

FIGS. 6A-6C depict cross-sectional side views of the crimping device ofFIGS. 5A-5D in operation.

DETAILED DESCRIPTION

Described here are devices, systems, and methods for treating one ormore sinus or nasal conditions with an implant. Also described here aredevices and methods for crimping an implant. Generally, the systemscomprise an implant sized and configured for placement in one or moreportions of the paranasal sinus or nasal cavities. The implant may bedelivered in a low-profile configuration, and may be expanded in theparanasal sinus or nasal cavity to dilate, separate, or otherwise pressagainst tissue, which in some instances may assist in opening an airwayof a patient. The implant may be configured to deliver or release one ormore drugs (e.g., to surrounding tissue). In some variations, thesystems may comprise a delivery device for delivering the implant intothe body. Additionally or alternatively, the systems may comprise acrimping device configured to place the implant in a low-profileconfiguration.

FIG. 1 shows an illustrative variation of the systems described here. Asshown there, the system may comprise an implant (100), a delivery device(200), and a crimping device (300). The implant (100) is generallymoveable between a low-profile configuration and an expandedconfiguration, and the crimping device (300) may be configured to movethe implant (100) from an expanded configuration to a low-profileconfiguration. The implant (100) may be releasably coupled to thedelivery device (200), which may be used to advance the implant (100) ina low-profile configuration into the body. The delivery device (200) mayrelease the implant (100) at a target location in the body (e.g., aparanasal sinus cavity, a nasal cavity, or the like), and the implant(100) may be expanded into contact with surrounding tissue. In somevariations, the implant (100) may self-expand when delivered.Additionally or alternatively, a separate device (e.g., a balloon) maybe used to expand the implant (100) (or, in the instances of aself-expanding implant, to aid in expansion of the implant). While thesystem is shown in FIG. 1 as comprising an implant (100), a deliverydevice (200), and a crimping device (300), it should be appreciated thatthe systems may comprise an implant only, may comprise an implant and adelivery device, may comprise an implant and a crimping device, or thelike. Each of the implant (100), delivery device (200), and crimpingdevice (300) will be described in more detail below.

FIGS. 2A-2F depict a variation of the implant (100) shown in FIG. 1 .Specifically, FIGS. 2A and 2B show side views of the implant (100). Asshown there, the implant may comprise a hub (102) and a plurality oflegs (103) extending from the hub (102). The legs (103) may be moveablebetween an expanded configuration, as shown in FIG. 2A, and alow-profile (e.g., unexpanded) configuration, as shown in a side view inFIG. 2B. Specifically, the legs (103) may rotate toward a longitudinalaxis (101) of the implant (100) to move the implant toward thelow-profile configuration, and may rotate away from the longitudinalaxis (101) to move the implant toward an expanded configuration. In somevariations, the implant may be configured to self-expand from thelow-profile configuration to the expanded configuration. In othervariations, the implant may be expanded (e.g., using a balloon or otherdevice) to move the implant from the low-profile configuration to theexpanded configuration. When positioned in the expanded configuration,the legs (103) of the implant may resist movement towards thelow-profile configuration, which may allow the legs (103) to support orotherwise press against tissue.

Generally, the hub (102) may act as a junction to join the plurality oflegs (103). In some instances the hub (102) may help facilitateadvancement of the implant (100) through tissue (e.g., by separatingtissue as the hub (102) is advanced therethrough), and/or may beconfigured to pierce tissue and/or at least partially anchor the implant(100) relative to tissue, as will be discussed in more detail below.FIG. 2C shows a side view of a variation of the hub (102). As shownthere the hub (102) may comprise a plurality of apertures (112)extending through the hub (102). The apertures (112) may be configuredto connect the legs (103) to the hub (102), as will be discussed in moredetail below. As shown there, the hub (102) may comprise a cylindricalportion (114) and a domed portion (116) at a distal end of the hub(102). The domed portion (116) may be configured to engage one or moreportions of a crimping device to align the implant (100) with thecrimping device, as will be described in more detail below. While shownin FIG. 2C as having both a cylindrical portion (114) and a domedportion (116), it should be appreciated that the hub (102) need notcomprise a domed portion (116), or may comprise a tapered portion havinga different profile than the domed portion (116). In some variations,the hub (102) may comprise a tapered portion with a pointed distal end,which may be configured to pierce tissue when the pointed distal end ispressed against tissue. In some of these variations, one or moreportions of the hub (102) may comprise one or more hooks or barbs, whichmay help to anchor the hub (102) relative to tissue. In othervariations, the hub (102) may not comprise a tapered portion. Forexample, in some variations cylindrical portion (114) may extend from aproximal end of the hub (102) to a distal end of the hub (102).

Additionally, while the hub (102) is shown in FIGS. 2A-2F as having acircular cross-sectional shape, it should be appreciated that the hub(102) may have any suitable cross-sectional shape (e.g., a circle, oval,rectangle, polygon, triangle, or the like). When the hub (102) comprisesa cylindrical portion (114) and a domed portion (116), the cylindricalportion (114) and the domed portion (116) may have the samecross-sectional shape, or may have different cross-sectional shapes. Insome variations, one or more portions of the hub (102) may be hollow.For example, in the variation of the hub (102) shown in FIGS. 2A-2F,each of the cylindrical portion (114) and the domed portion (116) may behollow. When an aperture (112) extends through a hollow portion of thehub (102), the aperture (112) may comprise first and second portionsthat may be separated by the hollow interior of the hub (102). Forexample, as shown in a cross-sectional side view in FIG. 2E, an aperture(112) may comprise a first aperture segment (112 a) extending throughthe hub (102) on a first side of the hollow interior (113) of the hub(102) and a second aperture segment (112 b) extending through the hub(102) on a second side of the hollow interior (113), such that the firstand second aperture segments are separated by the hollow interior (113)of the hub (102). Accordingly, the first aperture segment (112 a) andthe second aperture segment (112 b) may provide an open pathway throughthe hub (102), which may aid in the assembly of the implant, asdiscussed in more detail below.

Generally, the plurality of legs (103) of the implant may be formed froma plurality of filaments (104) that are attached to the hub (102). FIG.2D shows a side view of a variation of a filament (104) suitable for usewith the implants (100) described here. As shown there, the filament(104) may comprise a first straight segment (106), a second straightsegment (108), and a curved segment (110) positioned between the firststraight segment (106) and the second straight segment (108). In someinstances the first straight segment (106) may be connected to a firstend (117) of the curved segment (110) and the second straight segment(108) may be connected to a second end (119) of the curved segment(110), although it should be appreciated that the filament may compriseone or more additional straight or curved segments positioned betweeneither the first or second straight segments and the curved segment(110). In some instances, the first straight segment (106) may extendfrom the curved segment (110) at an angle (θ1) relative to a tangentline (120) of the curved segment (110) at the first end (117) of thecurved segment (110). Similarly, the second straight segment (108) mayextend from the curved segment (110) at an angle (θ2) relative to atangent line (122) of the curved segment (110) at the second end (119)of the curved segment (110). The angles (θ1) and (θ2) may be the same ormay be different, and may be any suitable value (e.g., between about 10degrees and about 60 degrees, between about 15 degrees and about 45degrees, less than 10 degrees, or the like). In some instances, one orboth of the angles (θ1) and (θ2) may be about 0 degrees, such that thefirst (106) and/or second (108) straight segments may extend parallel tothe tangent lines (120) and (122) respectively.

To attach the filaments (104) to the hub (102), each filament (104) maybe advanced through a respective aperture (112) and positioned such thata portion of the filament (104) extends through the hub (102). Forexample, FIGS. 2E and 2F depict cross-sectional side views of theimplant (100) with a filament (104) positioned through an aperture (112)of the hub (102) (only one filament (104) is shown there for the sake ofillustration). When the aperture (112) comprises a first aperturesegment (112 a) and a second aperture segment (112 b) separated by ahollow interior (113) of the hub (102) (as shown in FIGS. 2E and 2F),the filament (104) may be positioned such that a portion of the filament(104) extends through each of the first aperture segment (112 a), thesecond aperture segment (112 b), and the hollow interior (113).

The filament (104) may be positioned such that any suitable portion ofthe filament extends through the hub (102). For example, in thevariation shown in FIGS. 2E and 2F, the filament (104) may be positionedsuch that the curved segment (110) is positioned in the aperture (112)and extends through the hub (102). In these variations, positioning thecurved segment (110) to extend through the hub (102) may position afirst straight segment (106) of the filament (104) on a first side ofthe hub (102) and the second straight segment (108) on an opposite sideof the hub (102). Accordingly, when the filament (104) is positioned asshown in FIGS. 2E and 2F, the filament (104) may define two legs,specifically a first leg (103 a) defined by the portion of the filament(104) on a first side of the hub (102) (e.g., a portion of the curvedsegment (110) and the first straight segment (106)) and a second leg(103 b) defined by the portion of the filament (104) on the other sideof the hub (102) (e.g., a portion of the curved segment and the secondstraight segment (108)). Each leg may have a distal end (e.g., where theleg joins the hub (102)) and a proximal end (e.g., at the proximal endof the implant (100)). With the filament (104) positioned through thehub (102), the first (103 a) and second (103 b) legs may be rotatedrelative to the hub to move the legs between a low-profile configuration(as shown in FIG. 2E) and an expanded configuration (as shown in 2F). Insome variations, as mentioned above, the filament (104) may be biasedtowards the expanded configuration, which may allow the implant (100) toself-expand when forces holding the implant in a low-profileconfiguration are removed.

The implant (100) may comprise any number of filaments (104). When thefilaments (104) are positioned to extend through a hub (102), thefilaments (104) may in turn define twice as many legs (103). Forexample, in some variations the implant (100) may comprise two filaments(104), which may define four legs (103) when the filaments (104) arepositioned to extend through the hub (102). In other variations, theimplant (100) may comprise three filaments (104), which may define sixlegs (103) when the filaments (104) are positioned to extend through thehub (102). In yet other variations, such as the variation shown in FIGS.2A and 2B, the implant (100) may comprise four filaments (104), whichmay define eight legs (103) when the filaments (104) are positioned toextend through the hub (102). Additionally, the apertures (112) may bepositioned such that the plurality of filaments (104) have differentrotational orientations when each filament (104) is positioned in arespective aperture (112). For example, the apertures (112) may bepositioned in the hub (102) such that filaments (104) are evenly spacedaround the longitudinal axis of the implant. For example, in variationswhere the filament comprises four filaments (104), the filaments (104)may be positioned such that there is a 45 degree rotation betweenadjacent filaments (104), such that there is a 45 degree angle betweeneach leg (103) (e.g., when looking at the legs from a top of theimplant).

Generally, each leg (103) of the implant (100) may have any suitablelength between the proximal and distal end of the leg. In somevariations all of the legs (103) may have the same length. This lengthmay be any suitable value, for example, about between about 15 mm andabout 30 mm. In some of these variations, each leg (103) may have alength between about 20 mm and about 25 mm. In some of these variations,each leg (103) may have a length of about 20 mm. In others of thesevariations, each leg (103) may have a length of about 25 mm. In othervariations, different legs (103) of the implant may have differentlengths between proximal and distal ends of the respective legs. In someof these variations, the implant may comprise a first plurality of legshaving a first length between proximal and distal ends of each leg ofthe first plurality of legs and the a second plurality of legs having asecond length between proximal and distal ends of each leg of the secondplurality of legs, wherein the second length is longer than the firstlength. For example, in some variations the first length may be about 20mm and the second length may be about 25 mm. In some variations wherethe implant (100) comprises a first plurality of legs having a firstlength and a second plurality of legs having a second length, the firstand second plurality of legs are rotationally oriented such that thelegs (103) of the implant alternate between legs of the first pluralityof legs and the second plurality of legs (e.g., each leg of the firstplurality of legs may be rotationally positioned between two legs of thesecond plurality of legs). While the number of legs in the firstplurality of legs may be equal to the number of legs in the secondplurality of legs, it should be appreciated that the first plurality oflegs may have more legs than the second plurality of legs, or may havefewer legs than the second plurality of legs.

Generally, the filaments (104) may have any suitable cross-sectionalshape. For example, in the variation shown in FIGS. 2A-2F, the filaments(104) may have a rectangular cross-sectional shape. In other variations,the filaments (104) may have an oval cross-sectional shape. In stillother variations, the filaments (104) may have a circularcross-sectional shape. The apertures (112) may also have any suitableshape (e.g., a rectangle, oval, circle, or the like). In somevariations, the cross-sectional shape of the filament (104) may matchthe shape of aperture (112) in which the filament (104) is positioned.For example, in the variation shown in FIGS. 2A-2F, the apertures (112)may have a rectangular shape which corresponds to the rectangularcross-sectional shape of the filaments (104). In some variations, it maybe desirable to configure the filaments (104) and apertures (112) suchthat they have non-circular shapes. In these variations, thenon-circular nature of the filaments (104) and apertures (112) mayreduce or prevent rotation between the filaments (104) and the apertures(112). Additionally, the implant (100) may be configured to fix theplurality of filaments (104) relative to their respective apertures(112). For example, in some variations the filaments (104) may be bonded(e.g., via one or more adhesives or thermal bonding), welded (e.g., viaultrasonic welding), or press-fit to the hub (102).

The implants (100) described above may be formed in any suitable manner.Generally, forming the implant may comprise forming a hub comprising aplurality of apertures extending therethrough, forming a plurality offilaments, and advancing each filament through a respective aperturesuch that a portion of the filament extends through the hub. The hub andfilaments may be formed in any suitable manner (e.g., extrusion,injection-molding, blow-molding, vacuum-formation, casting, or thelike), and the hub and filaments may be formed using the same processingtechniques or different processing techniques. In some variations,forming the plurality of filaments may comprise extruding the pluralityof polymer filaments. In some of these variations, forming the hub maycomprise forming the hub using injection molding. In others of thesevariations, forming the hub may comprise extruding the hub. In others ofthese variations, the hub may be formed from a laser-cut tube.

Additionally, in some variations, forming the plurality of filaments mayinclude shaping each filament such that the filament comprises one ormore straight and/or curved segments, such as discussed above. Forexample, in some of these variations, some or all of the filaments maybe shaped such that the filaments have a first straight portion, asecond straight portion, and a curved segment between the first andsecond straight portions. In some of these variations, advancing eachfilament through a respective aperture in the hub may includepositioning a filament in the aperture such that the curved segmentextends through the hub. In some variations, once the filaments havebeen advanced through the hub, the filaments may be fixed relative tothe hub to prevent the filament from sliding relative to the hub. Thismay be done, for example, by bonding (e.g., thermal bonding, adhesivebonding) or welding (e.g., ultrasonic welding) the filaments to the hub.

Generally, the implant may be formed from any suitable material orcombinations of materials. In some variations, the hub and/or thefilaments may be formed from one or more materials that arebiodegradable, bioerodable, or otherwise erodible. In some variations,the plurality of filaments may be biodegradable, but the hub may not be(or vice versa). In other variations, both the hub and the filaments maybe biodegradable. In still other variations, neither the hub nor thefilaments may be biodegradable. While in some instances the hub and theplurality of filaments may be formed from the same material ormaterials, in other variations the hub may be formed from a differentmaterial or materials than the material or materials of the plurality offilaments.

In some variations, the hub and/or the plurality of filaments may beformed from one or more polymers. When both the hub and the plurality offilaments are formed from one or more polymers, the hub may be formedfrom the same polymer (or polymers) as the filaments or may be formedfrom different polymers than the filaments. The polymers may bebiodegradable, but need not be. Examples of biodegradable polymers thatmay be suitable for use with the implants describe here include, but arenot limited to, aliginate, cellulose and ester, dextran, elastin,fibrin, hyaluronic acid, polyacetals, polyarylates (L-tyrosine-derivedor free acid), poly(α-hydroxy-esters), poly(ß-hydroxy-esters),polyamides, poly(amino acid), polyalkanotes, polyalkylene alkylates,polyalkylene oxylates, polyalkylene succinates, polyanhydrides,polyanhydride esters, polyaspartimic acid, polybutylene diglycolate,poly(caprolactone), poly(caprolactone)/poly(ethylene glycol) copolymers,poly(carbonate), L-tyrosine-derived polycarbonates, polycyanoacrylates,polydihidropyrans, poly(dioxanone), poly-p-dioxanone,poly(epsilon-caprolactone),poly(epsilon-caprolactone-dimethyltrimethylene carbonate),poly(esteramide), poly(esters), aliphatic polyesters, poly(etherester),poly(ethylene glycol)/poly(orthoester) copolymers, poly(glutarunicacid), poly(glycolic acid), poly(glycolide),poly(glycolide)/poly(ethylene glycol) copolymers,poly(glycolide-trimethylene carbonate), poly(hydroxyalkanoates),poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), poly(iminocarbonates), polyketals, poly(lactic acid), poly(lactic acid-co-glycolicacid), poly(lactic acid-co-glycolic acid)/poly(ethylene glycol)copolymers, poly(lactide), poly(lactide-co-caprolactone),poly(DL-lactide-co-glycolide), poly(lactide-co-glycolide)/poly(ethyleneglycol) copolymers, poly(lactide)/poly(ethylene glycol) copolymers,poly(lactide)/poly(glycolide) copolymers, polyorthoesters,poly(oxyethylene)/poly(oxypropylene) copolymers, polypeptides,polyphosphazenes, polyphosphoesters, polyphosphoester urethanes,poly(propylene fumarate-co-ethylene glycol), poly(trimethylenecarbonate), polytyrosine carbonate, polyurethane, PorLastin orsilk-ealastin polymers, spider silk, tephaflex, terpolymer (copolymersof glycolide, lactide or dimethyltrimethylene carbonate), andcombinations, mixtures or copolymers thereof. Examples ofnonbiodegradable polymers suitable for use with the methods and devicesdescribed herein include, but are not limited to poly(ethylene vinylacetate), poly(vinyl acetate), silicone polymers, polyurethanes,polysaccharides such as a cellulosic polymers and cellulose derivatives,acyl substituted cellulose acetates and derivatives thereof, copolymersof poly(ethylene glycol) and poly(butylene terephthalate), polystyrenes,polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole),chorosulphonated polyolefins, polyethylene oxide, and copolymers andblends thereof. In variations where the implant comprisespoly(lactic-co-glycolic acid), the molar percent of lactide or the molarpercent of glycolide may be any suitable amount, for example, betweenabout 0% and about 100%, between about 30% and about 100%, between about50% and about 100%, between about 70% and about 100%, between about 0%and about 70%, between about 30% and about 70%, between about 50% andabout 70%, between about 0% and about 50%, between about 30% and about50%, between about 0% and about 50% and the like. In some variations,the molar ratio of lactide to glycolide is about 10:90, about 85:15,about 15:85, or the like. In variations where the implant comprises apoly(lactic-co-glycolic acid)/poly(ethylene glycol) copolymer, thecopolymer may include any suitable amounts of poly(lactic-co-glycolicacid) and poly(ethylene glycol). For example, in some variations thecopolymer may comprise about 90% poly(lactic-co-glycolic acid) and about10% poly(ethylene glycol). It should be further appreciated that thepoly(lactic-co-glycolic acid) may have any suitable molar percentages oflactide and glycolide, as described above. Examples of other suitablematerials may be found in U.S. patent application Ser. No. 12/779,240,filed on May 13, 2010 and titled “Expandable Devices and MethodsTherefor,” the content of which is hereby incorporated by reference inits entirety.

In some variations, the implant may be configured to release one or moredrugs therefrom. The implant may be configured to release any suitabledrugs or agents, such as those described in U.S. patent application Ser.No. 12/779,240, which was previously incorporated by reference. Forexample, in some variations the implant may be configured to release oneor more steroids, such as mometasone furoate. The implant may beconfigured to release one or more drugs in any suitable manner. In somevariations, the implant may comprise one or more drug-releasingcoatings, such as those described in U.S. patent application Ser. No.12/779,240, which was previously incorporated by reference. In othervariations, the hub and/or one or more of the filaments may beconfigured to elute or otherwise release one or more drugs therefrom.The selection of drugs, the timing of delivery, and the overall amountof drug or drugs released may be determined by the intended treatmentplan, and may be further fine-tuned to the meet the specific needs of anindividual patient.

The implants described here may be delivered using any suitable deliverydevice, such as, for example, the delivery device (200) shown in FIG. 1. As shown there, the delivery device (200) may comprise a handle (202),an inner shaft (204), and an outer sheath (206). FIGS. 3A and 3B showside views of a distal portion of the delivery device (200). As shownthere, the inner shaft (204) may comprise a ball tip (207) and anengagement sleeve (208) covering a portion of the inner shaft (204). Theouter sheath (206) may comprise a distal cup (210), which will bedescribed in more detail below.

Generally, the inner shaft (204) may be positioned at least partiallywithin the outer sheath (206), and the inner shaft (204) may be moveablerelative to the outer sheath (206). The handle (202) may be configuredto move the inner shaft (204) relative to the outer sheath (206). Forexample, in the variation of the delivery device (100) shown in FIG. 1 ,the handle (202) may comprise one or more proximal grips (212) and oneor more distal grips (214). The proximal grips (212) may be moveablerelative to the distal grips (214) to move the inner shaft (204)relative to the outer sheath (206). For example, handle (202) may beconfigured such that advancement of the proximal grips (212) toward thedistal grips (214) advances the inner shaft (204) relative to the outersheath (206) (as shown in FIG. 3A), and retraction of the proximal grips(212) away from the distal grips (214) retracts the inner shaft (204)relative to the outer sheath (206) (as shown in FIG. 3B).

To load an implant (such as implant (100) depicted in FIG. 1 ) into thedelivery device (200), the inner shaft (204) may be advanced relative tothe outer sheath (206) (as shown in FIG. 3A), and a tip of the innershaft (204) may be positioned in, against, or near the hub (102) of theimplant (100). The legs (103) of the implant may be moved to alow-profile configuration (e.g., using a crimping device, as will bedescribed in more detail below) around the inner shaft (204). With thelegs (103) of the implant (100) in a low-profile configuration, theouter sheath (206) may be advanced relative to the inner shaft (204) toadvance the distal cup (210) over a portion of the legs (103) of theimplant. The distal cup (210) may retain the legs (103) in a low-profileconfiguration until delivery of the implant (100). To deliver theimplant (100), the outer sheath (206) may be retracted relative to theinner shaft (204) to retract the distal cup (210), which may in turnexpose the legs (103). When exposed, the legs (103) may expand or beexpanded to deliver the implant (100). Loading of the delivery device(200) and delivery of the implant (100) will be described in more detailbelow.

While the inner shaft (204) is shown in FIGS. 3A and 3B as having a balltip (207) and an engagement sleeve (208), it should be appreciated thatin some variations, the delivery device (200) may comprise only one ofthese features (e.g., either a ball tip (207) or an engagement sleeve(208)) or may not include either of these features. In variations wherethe delivery device (200) comprises a ball tip (207), the ball tip (207)may facilitate engagement of the delivery device (200) with an implant.Specifically, when the inner shaft (204) is used to push against the hubof implant (e.g., to crimp the implant using one of the crimping devicesdescribed here, as will be discussed in more detail below), the roundednature of the ball tip (207) may cause the ball tip (207) to slide atleast partially into a hollow portion of the hub, which may act tocenter or otherwise locate the ball tip (207) relative to the hub of theimplant.

In variations of the delivery devices (200) described here where theinner shaft (204) comprises an engagement sleeve (208), the engagementsleeve (208) may be configured to grip or otherwise increase africtional force between the inner shaft (204) and one or more legs(103) of the implant (100). Specifically, when the legs (103) of theimplant are moved to a low-profile configuration around the inner shaft(204), one or more portions of the legs (103) (e.g., a straight segmentof the leg) may contact the engagement sleeve (208). In some variations,the engagement sleeve (208) may comprise a flexible material (e.g., afoam, silicon, or the like), such that contact between the legs (103)and the engagement sleeve (208) may temporarily form a depression in theengagement sleeve (208), which may help to hold the leg (103) relativeto the engagement sleeve (208). Additionally or alternatively, theengagement sleeve (208) may be roughened, patterned, or otherwise have ahigher coefficient of friction than the inner shaft (204), which mayreduce the ability of the legs (103) to slip relative to the engagementsleeve (208) (and thus the delivery device (200). It should beappreciated that the implants described here may be delivered using anysuitable implant, such as those described in U.S. patent applicationSer. No. 12/779,240, which was previously incorporated by reference.

Also described here are devices for crimping expandable devices.Generally the crimping devices described here may be configured to crimpan implant having a plurality of legs. While the crimping devices aredescribed here as being used to crimp the implant (100) described abovewith respect to FIGS. 1 and 2A-2F, the crimping devices may be any usedto crimp any suitable multi-leg implant, such as those described in U.S.patent application Ser. No. 12/779,240, which was previouslyincorporated by reference.

Returning to FIG. 1 , the crimping device (300) may comprise a housing(302) and a crimping member (304). Generally, the housing (302) maycomprise an outer housing (306) and an inner housing (308). The outerhousing (306) may be sized and shaped to be held by a user, and theinner housing (308) may be configured to interact with the crimpingmember (304) to crimp an implant to a low-profile configuration, as willbe discussed in more detail below. The inner housing (308) and the outerhousing (306) may be formed as a single member, or may be formedseparately and joined together. The components of the housing may beformed from any suitable material, such as one or more metals (e.g.,stainless steel), plastics (e.g., polyurethane, polycarbonate,polypropylene, or the like), combinations thereof and the like.

As mentioned above, the crimping member (304) may interact with theinner housing (308) to crimp an implant. To illustrate this, FIGS. 4Aand 4B depict exploded perspective and cross-sectional side views,respectively, of the inner housing (308) and the crimping member (304)(the outer housing (306) is not depicted in FIGS. 4A-4F). As shownthere, the crimping member (304) may comprise a stem portion (310) and aplurality of arms (312) radially extending from the stem portion (310).Each of the arms (312) may be rotatably connected to the stem portion(310) at a joint (314) such that the arms (312) may be rotated toward oraway from a longitudinal axis (316) of the crimping member (304). Torotate the arms (312) relative to the stem portion (310), the crimpingmember (304) may be withdrawn into a recess (320) of the inner housing(308).

Specifically, the recess (320) may comprise a central recess (322) and aplurality of channels (324) extending radially from the central recess(322). The crimping member (304) may be positioned at least partially inthe recess (320) to position the stem portion (310) at least partiallywithin the central recess (322), and may be moved between an openconfiguration (as shown in FIG. 4C) and a crimping configuration (asshown in FIG. 4D). Generally, the length between a center of the stemportion (310) and a distal end of each arm (312) may be greater than thedistance between a center of the central recess (322) to an outer edge(326) of each channel (324). When the crimping member is positioned inthe open configuration, each arm (312) may be positioned in acorresponding channel (324) such that the distal end of each arm (312)extends beyond the outer edge (326) of the corresponding channel (324).To move the crimping member (304) to the crimping configuration, thestem portion (310) may be pushed, pulled, or otherwise moved furtherinto the central recess (322) (e.g., toward a bottom surface (328) ofthe central recess (322)). As the stem portion (310) is moved toward thebottom surface (328), each arm (312) of the crimping member may bepulled into contact with the outer edge (326) of the correspondingchannel (324), and the outer edge (326) may act as a fulcrum to rotateeach arm (312) relative to the stem portion (310). This may rotate eacharm (312) toward a longitudinal axis (316) of the crimping member (304).Additionally, as the arms (312) rotate relative to the stem portion(310), the arms may be drawn at least partially into their respectivechannels (324) to place the crimping member (304) in the crimpingposition, as shown in FIG. 4D. During rotation of the arms (312), thearms (312) may engage and move the legs of an implant to crimp theimplant to a low-profile configuration, as will be described in moredetail below. To return the crimping member (304) to the openconfiguration (as shown in FIG. 4C), the stem portion (310) may be movedaway from the bottom surface (328) of the central recess (322) which mayadvance the arms (312) at least partially out of the channels (324). Asthe arms (312) exit the channels (324), they may be configured to rotateaway from the longitudinal axis (316) of the crimping member (304).

In some variations, the crimping device (300) may comprise a spring(330) positioned between the stem portion (310) of the crimping member(304) and the bottom surface (328) of the central recess (322). Thespring (330) may bias the crimping member (304) towards the openconfiguration shown in FIG. 4C. As the crimping member (304) is movedinto the recess (320) to crimp an implant, the crimping member (304) maypush against the spring (330) and may compress the spring (330). Whenthe force or forces that moved the crimping member (304) into the recess(320) are removed, the spring may decompress to return the crimpingmember (304) to the open configuration.

In some variations, the crimping device (300) may be configured suchthat the crimping member (304) may not be completely released from therecess (320) of the inner housing (308). For example, in some variations(such as shown in FIG. 4B), the crimping member (304) may comprise oneor more latches (332), which may be configured to catch or otherwiseengage a portion of the inner housing (308) when the crimping member(304) is moved from the crimping configuration to the openconfiguration. This engagement between the latch (332) and the innerhousing may prevent further movement of the crimping member (304) awayfrom the inner housing (308). In other variations, the crimping member(304) may comprise a pin (not shown) that extends through an opening(334) in the bottom surface (328) of the central recess (322). The pinmay be slidable relative to the bottom surface (328), and may comprise astop (e.g., a portion of the pin or a member attached thereto having adiameter greater than that of the opening (334)) that is positionedbeneath an opposite side of the bottom surface (328) as the rest of thecrimping member (304). When the crimping member (304) is moved from thecrimping configuration to the open configuration, the stop may beprevented from passing through the opening (334), and may preventfurther movement of the crimping member (304) away from the recess(320).

The arms (312) may be configured to rotate relative to stem portion(310) in any suitable manner. In some variations, the joint (314) maycomprise a pin joint that connects the arm (312) to the stem portion(310). In other variations, the arm (312) may be configured to rotatevia deformation of a portion of the arm. For example, in somevariations, such as that shown in FIGS. 4A-4F, the joint (314) maycomprise a living hinge. In these variations, the material of the livinghinge that connects an arm (312) to the stem portion (310) may be biasedaway from the longitudinal axis (316) of the crimping member (304), suchthat when the crimping member (304) is moved from the crimpingconfiguration to the open configuration, the arm (302) may be configuredto rotate away from the longitudinal axis (316) of the crimping member(304). Additionally or alternatively, the arms (312) may comprise one ormore spring members (not shown) configured to rotate the arms (312) awayfrom the longitudinal axis (316) of the crimping member (314) as thecrimping member (304) is moved from the crimping configuration to theopen configuration.

Each leg of an implant may be engaged by a respective arm (312) of thecrimping member (304), such that rotation of the arms (312) toward thelongitudinal axis (316) of the crimping member (304) also may rotate thelegs of the implant relative to a low-profile configuration. To engage aleg of an implant, an arm (312) of the crimping member (304) maycomprise one or more holders (317). Generally, a holder (317) may extendfrom a corresponding arm (312) and may comprise a channel (318) sizedand configured to receive a portion of the leg of the implant. When theimplant is initially positioned relative to the crimping member (304),each leg may be positioned in the channels (318) of the one or moreholders (317) of a corresponding arm (312). When positioned in thechannels (318) of one or more holders (317), each leg may be moved witha corresponding arm (312) as that arm (312) rotates relative to the stemportion (310). Each arm (312) of the crimping member (304) may compriseany suitable number of holders (e.g., one, two, three, or four or moreholders). For example, the arms (312) are shown in FIG. 4A as eachhaving three holders (317) and are shown in FIGS. 4B-4F as each havingtwo holders (317). In other variations, the arms (312) may not compriseany holders (317). In some of these variations, the arm may comprise achannel extending along a portion of length of the arm (312), and thechannel may be sized and configured to receive a portion of the leg ofan implant, which may allow the arm itself to act as a holder aspreviously discussed.

In some variations, the height of one or more arms (312) of the crimpingmember (304) may vary along the length of the arm. For example, in thevariation of the crimping device shown in FIGS. 4A-4F, the arms (312)may each comprise a wing portion (336), in which the height of the wingincreases along the wing portion from a proximal end (338) of the wingportion (336) to a distal end (340) of the wing portion (336). When thearms (312) are pulled into the channels (324) of the recess (320) of theinner housing (308), the increasing height of the wing portion (336) maybring an upper surface of each arm (312) closer to the longitudinal axis(316) of the stem portion (310). When the arms (312) include one or moreholders (317) or are otherwise configured to engage the legs of animplant, the increasing height of the wing portions (336) may allow thearms (312) to bring the legs closer to a longitudinal axis of theimplant, thereby increasing the degree of crimping of the implant.

In some variations, the stem portion (310) may also comprise one or morestructures configured to engage a portion of the implant. For example,in the variation of the crimping device (300) shown in FIGS. 4E-4F, thestem portion (310) may comprise an indentation (319) sized to receive aportion of the hub of an implant. In these variations, a hub of animplant may be positioned such that at least a portion of the hub restswithin the indentation (319) of the stem portion (310). This may allowfor repeatable positioning of the implant relative to the crimpingmember (304), and may also reduce or prevent shifting or slipping of theimplant relative to the crimping member (304) during crimping. Forexample, in some variations, the indentation (319) may comprise ahemispherical portion. When the hub of an implant comprises a domedportion (such as described in more detail above), the domed portion ofthe hub may be centered in the hemispherical portion of the indentation(319), which may help to align the implant relative to the crimpingmember (304). Additionally, in some variations (such as shown in FIGS.4A and 4C) the stem portion (310) may additionally comprise one or moreslots (329) extending radially from the indentation (319). Each slot(329) may be aligned with an arm (312) of the crimping member (304), andmay be sized to receive a portion of a leg of an implant when a hub ofthe implant is position in the indentation (329). Accordingly, a slot(329) may act as a keyway slot which may prevent or limit rotation ofthe implant relative to the crimping member (304) when a leg is at leastpartially positioned in the slot (329). While shown in FIGS. 4A and 4Cas having four slots (329), the stem portion (310) of the crimpingmember (304) may have any suitable number of slots (e.g., one, two,three, four, or five or more slots). In some variations, the stemportion (310) may comprise at least as many slots (329) as the crimpingmember (304) has arms (312). In these variations, a slot (329) may bealigned with each arm (312) of the crimping member. In some variationswhere the stem portion (310) comprises an indentation and/or one or moreslots configured to receive one or more portions of an implant, theindentation and/or slots may be sized and configured to form a press fitwith the implant to temporarily hold the implant relative to the stemportion (310). In these variations, the implant may be pulled away fromthe stem portion (310) (e.g., using a delivery device) to disengage theimplant from the stem portion (310).

FIGS. 4E and 4F depict a manner in which the crimping member (304) maybe used to crimp the implant (100) (described above with respect toFIGS. 1 and 2A-2F) to a low-profile configuration. It should beappreciated, however, that the crimping device may be used to crimp anysuitable device, such as discussed above. As shown in FIG. 4E, theimplant (100) may be positioned such that each leg (103) of the implant(100) is engaged by a corresponding arm (312) of the crimping member(304). In variations where the arms (312) comprise one or more holders(317), one or more of the legs (103) may positioned within channels(318) of one or more holders (317) of the corresponding arms (312) (itshould be appreciated that the number of holders (317) of a given arm(312) that engage a leg (103) may increase during the crimping).Additionally, the hub (102) of the implant may be positioned to engagethe stem portion (310) of the crimping member (312). For example, asshown in FIG. 4E, at least a portion of the hub (102) may be positionedwithin an indentation (319) in the stem portion (310). In someinstances, this may act to align the implant (100) relative to thecrimping member (304). In some variations, one or more of the legs (102)may be positioned corresponding slots (329) of the stem portion (310),which may further align the implant (100) relative to the crimpingmember (304). In some variations, the indentation (319) and/or slots(329) may temporarily hold the implant (100) in place relative to thestem portion (310).

With each leg (103) of the implant engaged by a corresponding arm (312)of the crimping member (304), the crimping member may be moved into therecess (320) of the inner housing (308) (which is not shown in FIGS. 4Eand 4F) to move the crimping member (304) from an open configuration toa crimping configuration. As discussed above, this may cause the arms(312) to rotate toward the longitudinal axis of the stem portion (310)at the joints (314), and the engagement between the legs (102) and therespective arms (312) of the crimping member (304) may cause the arms(312) to rotate the legs (102) toward a low-profile configuration, asillustrated in FIG. 4F. The crimped implant (100) may also be coupled toa delivery device and delivered to the body, as will be described inmore detail below.

In some variations, a delivery device may assist in the operation of thecrimping device. For example, FIGS. 4E and 4F depict how the deliverydevice (200) described above with respect to FIGS. 1, 3A, and 3B may beused with the crimping device (300) to crimp the implant (100). Itshould be appreciated that the crimping device (300) may be used inconjunction with any suitable delivery device, or may be operatedindependently of a delivery device. When the crimping member (304) isplaced in an open configuration and the implant (100) is positioned suchthat each leg (103) of the implant is engaged by a respective arm (312)of the crimping member (304), as discussed above with respect to FIG.4E, the delivery device (200) may be configured to engage a portion ofthe implant (100). Specifically, a distal tip of the inner shaft (204)(e.g., the ball tip (207)) may be placed into contact with the hub (102)of the implant (100) to press the hub (102) against the stem portion(310) of the crimping member (304), as shown in FIG. 4E. When the hub(102) is at least partially hollow, at least a portion of the tip of theinner shaft (204) may extend at least partially into the hollow interiorof the hub (102). When a portion of the hub (102) is positioned withinan indentation (319) of the stem portion (310), the force applied by theinner shaft (204) to the hub (102) may help to hold the hub (102)relative to the indentation (319). This may reduce the likelihood thatthe implant (100) will shift relative to the crimping member (304)during crimping.

With the inner shaft (204) pressed against the hub (102), the deliverydevice (200) may be advanced to push the crimping member (304) into therecess (320) of the inner housing (308). In some variations, the outersheath (206) and distal cup (210) may be retracted relative to the innershaft (204) prior to or during the movement of the crimping member (304)into the recess (320). As the crimping member (304) is pushed into therecess (320), the crimping member (304) may move from an openconfiguration to the crimping configuration, which may rotate the legs(103) relative to the hub (102) into a low-profile configuration, asdiscussed above. Rotation of the legs (103) to the low-profileconfiguration may position the legs (103) into contact with orsubstantially parallel to the inner shaft (204) of the delivery device,such as shown in FIG. 4F. In some variations, the legs (103) of theimplant (100) may contact or otherwise engage an engagement sleeve (208)of the inner shaft (204). With the arms (312) of the crimping member(304) holding the legs in a low-profile configuration, the outer sleeve(206) of the delivery device (200) may be advanced relative to the innershaft (204) to advance the distal cup (210) to cover at least a portionof the legs (103). This may act to hold the legs (103) of the implant(100) between the distal cup (210) and the inner shaft (204) of thedelivery device (200), and thus may couple the implant (100) thereto.

With the delivery device (200) coupled to the implant (100), thedelivery device (200) may then be withdrawn relative to the crimpingmember (304). This may cause the crimping member (304) to return to theopen configuration (e.g., due to the biasing force provided by a spring(330) as discussed above), which release the engagement between thecrimping member (304) and the implant (100). The delivery device (200)may then be used to deliver the implant to a target location within apatient's body. To deliver the implant (100), the distal cup (210) maybe withdrawn (e.g., by retracting the outer sheath (206) relative to theinner shaft (204)) to expose the legs (103) of the implant (100). Theimplant (100) may then be expanded (either by self-expansion or via adevice such as a balloon) in the patient to press against, dilate, orotherwise hold tissue in the patient.

FIGS. 5A-5D depict another variation of a crimping device (500)described here. Specifically, FIGS. 5A-5D show perspective, top, side,and cross-sectional side views, respectively, of the crimping device(500). As shown there, the crimping device may comprise a housing (502)defining a crimping chamber (504) extending at least partially into thehousing (502) from a proximal opening (512) in the housing (502). Asshown in FIG. 5D, the crimping chamber (504) may comprise a firstsegment (506), a second segment (508), and a third segment (510) Thefirst segment (506) of the crimping chamber (504) may extend between aproximal opening (512) in the housing (502) to a proximal end of thesecond segment (508). The second segment (508) may, in turn, extend froma distal end of the first segment (506) to a proximal end of the thirdsegment (510), while the third segment (510) may extend from a distalend of the second segment (508) to a distal end (514) of the crimpingchamber (504). In some variations, the housing (502) may comprise adistal opening at a distal end (514) of the crimping chamber (504).

The housing (502) may comprise a plurality of ribs (516) positioned inthe crimping chamber (504). The plurality of ribs (516) may define aplurality of channels (518) in the crimping chamber (504), with eachchannel (518) defined between adjacent ribs (516). The ribs (516) mayextend through some or all of the segments of the crimping chamber(504). For example, in the variation shown in FIGS. 5A-5D, the pluralityof ribs (516) and plurality of channels (518) may extend through each ofthe first segment (506), second segment (508), and third segment (510).In some of these variations, the plurality of ribs (516) and pluralityof channels (518) may extend from a proximal end of the crimping chamberto a distal end of the chamber. In others of these variations, theplurality of ribs (516) and the plurality of channels (518) may extendonly partially through the first segment and/or third segment (510). Forexample, in the variation shown in FIGS. 5A-5D, the plurality of ribs(516) and plurality of channels (518) may extend from the distal end ofthe third segment (510), along the second segment (508), and partiallyalong the first segment (506) (e.g., the ribs (516) may terminatedistally of the proximal opening (512) of the housing (502)).Additionally or alternatively, the ribs (516) and channels (518) mayextend along only a portion of the third (510) segments.

In some variations, one or more of the first segment (506), secondsegment (508), and third segment (510) may not have any ribs (516)positioned in that segment. For example, in some variations the firstsegment (506) may not include any ribs (516). In some of thesevariations, the housing (502) may comprise a plurality of ribs (516)which may extend at least partially through the second segment (508) andat least partially through the third segment (510). In other variations,the second segment (508) may not include any ribs (516). In some ofthese variations, the first segment (506) may comprise a first pluralityof ribs (516) and the third segment (510) may comprise a secondplurality of ribs. In some variations, the first plurality of ribs (516)may have the same number of ribs (516) as the second plurality of ribs(516), and in some of these variations, each rib of the first pluralityof ribs (516) may be aligned with a corresponding rib of the secondplurality of ribs (516).

It should be appreciated that in some instances, different ribs (516) ofthe plurality of ribs (516) may extend through different segments orcombinations of segments, such that different segments of the crimpingchamber (504) may have differing numbers of ribs (and thus differingnumber of channels) positioned therein. For example, in some variations,the plurality of ribs (516) positioned in the crimping chamber (504) maycomprise a first plurality of ribs (516) which may extend at leastpartially along each of the first segment, second segment, and thirdsegment, and a second plurality of ribs (516) which may extend at leastpartially along the first segment. In these variations, the firstsegment (506) may include a first number of ribs and the second segment(508) and third segment (510) may include a second number of ribs lessthan the first number of ribs.

Generally, each segment of the crimping chamber (504) may have an innerdiameter and an outer diameter. Generally the outer diameter mayrepresent the outermost profile of the crimping chamber (504), while theinner diameter may represent a profile of the crimping chamber (504)that represents unobstructed space within the crimping chamber (504).The wall of the housing (502) may define the outer diameter of thecrimping chamber (504). In portions of the crimping chamber (504) thatdo not include ribs (516), the inner diameter may be equal to the outerthe diameter. In portions of the crimping chamber that do include aplurality of ribs (516) extending inwardly from wall of the housing(502), the tips of the ribs (516) may define the inner diameter of thecrimping chamber (504). In these variations, the channels (518) definedbetween adjacent ribs (516) may extend from the inner diameter to theouter diameter. Accordingly, the depth of each channel (518) may bedefined by the height of the adjacent ribs (516).

Each segment of the crimping chamber (504) may have any suitable innerand outer diameters. For example, when the crimping chamber (504) isused to crimp an implant having a plurality of legs moveable between alow-profile and an expanded configuration (such as implant 100 describedabove), the first segment (506) may be configured to house the implantin its expanded (e.g., uncrimped) configuration. In these variations, atleast a portion of the first segment (506) may have an outer diametergreater than or equal to the largest diameter of implant. For example,in variations where the crimping device (500) is configured to crimp avariation of the implant (100) described above with respect to FIGS.2A-2D, at least a portion of the first segment (506) may have an outerdiameter greater than or equal to a diameter defined by the proximalends of the legs (103).

In some variations, such as that shown in FIGS. 5A-5D, the outerdiameter of first segment (506) may be tapered between a first diameterat a proximal end of the first segment (506) and a second diameter at adistal end of the first segment (506). For example, in some variations,the outer diameter of the first segment (506) may taper between about 30mm at a proximal end of the first segment (506) and about 8 mm at adistal end of the first segment (506). As used here, “about” means±5%.In other variations, the outer diameter of the first segment (506) maytaper between about 25 mm at a proximal end of the first segment (506)and about 8 mm at a distal end of the first segment (506). In some ofthese variations, the inner diameter of the first segment (506) maytaper between a proximal end of the first segment (506) to the distalend of the first segment (506). The tapering outer diameter of the firstsegment (506) may assist in crimping of the implant, such as describedin more detail below. It should be appreciated that while the entirefirst segment (506) is shown in FIGS. 5A-5D as having a tapered outerdiameter, it should be appreciated that in some instances one or moreportions of the first segment (506) may have a uniform outer diameter.For example, in some variations, the first segment (506) may comprise adistal portion having an outer diameter that tapers between a firstdiameter and a second diameter smaller than the first diameter, and aproximal portion having a uniform outer diameter which may be greaterthan or equal to the first diameter.

In variations in which the first segment (506) comprises a plurality ofribs (516) and channels (518) extending at least partially along thefirst segment (506), the legs of the implant may be at least partiallypositioned within the plurality of channels (518) when the implant ispositioned in the first segment (506), which may align the implantrelative to the crimping chamber (504). In some variations, each leg maybe positioned in a separate channel (518). In these variations, firstsegment (506) of the crimping chamber (504) may have at least as manychannels (518) as legs of the implant. In other variations, multiplelegs (e.g., two, three, or more legs) may be positioned in individualchannels (518) of the first segment (506). In these variations, thefirst segment (506) may have fewer channels (518) than the number oflegs of the implant. While the first segment (506) is shown in FIGS.5A-5D as having eight ribs (516) defining eight channels (518), itshould be appreciated that the first segment (506) may include anysuitable number of ribs and channels (e.g., two, three, four, five, six,or seven or more ribs and channels).

In some variations, the housing (502) may comprise a lip (520) locatedat the proximal end of the crimping chamber (504). The lip (520) mayextend inward from the housing (502) to define an opening smaller thanmay be smaller than the outer diameter of the proximal end of the firstsegment (506). The opening of the lip (520) may define the proximalopening (512) of the crimping chamber (504). Accordingly, the diameterof the proximal opening (512) may be smaller than the outer diameter ofthe proximal end of the first segment (506). In some of thesevariations, having a proximal opening (512) with a diameter smaller thanthe outer diameter of the proximal end of the first segment (506) mayhelp to temporarily hold the implant within the crimping chamber (504).For example, the diameter of the opening of the lip (520) may be smallerthan the largest diameter of an implant in when in an expandedconfiguration (e.g., the diameter defined by the proximal ends of thelegs (103) of implant (100) in the expanded configuration). Accordingly,when the implant is placed in the first segment (506) in an expandedconfiguration, the implant may be temporarily prevented from exiting thecrimping chamber (504) through the proximal opening (512). To remove theimplant from the crimping chamber (504), the implant may be moved froman expanded configuration to a low-profile configuration, as discussedin more detail below.

In some instances, the lip (520) may be formed integrally with thehousing (502). In other variations, such as shown in FIGS. 5A-5D, thelip (520) may be formed as part of a cap (524) that may be connected tothe housing (502). In some instances, the cap (524) may be removablyconnected to from the housing (502). In these variations, the cap (524)may be disconnected from the housing (502) to remove the lip (520) fromthe housing (502). This in turn, may increase the size of the proximalopening (512) of crimping chamber (504), which may facilitate placementof an implant (e.g., implant (100)) into the crimping chamber (504). Thecap (524) may then be connected to the housing (502) (e.g., which mayreduce the size of the proximal opening (512)). which may hold theimplant (e.g., implant (100)) in the crimping chamber (504) as discussedimmediately above. In instances where the lip (520) is integrally formedas part of the housing (502) or a cap (524) comprising the lip (520) isfixedly attached to the housing (502), an implant (e.g., implant (100))may be inserted into the first segment (506) of the crimping chamber(504) past the lip (520) by temporarily moving the implant toward thelow-profile (e.g., crimped) configuration (e.g., by flexing the legs(103) of implant (100) toward a low-profile configuration), totemporarily reduce the outer profile of the implant, and inserting theimplant into the proximal opening (512) of the crimping chamber (504).In some of these instances, the implant may return toward the expandedconfiguration after being inserted past the lip (520) into the firstsegment (506).

When an implant is positioned in the first segment (506) of the crimpingchamber (504), the implant may be moved from the first segment (506) tothe second segment (508) to crimp or partially crimp the implant.Generally, the second segment (508) may have an outer diameter thatcorresponds to a desired outer profile of the implant. For example, invariations where it may be desirable to reduce the implant to a diameterof about 8 mm, the outer diameter of the second segment (508) may beabout 8 mm. It should also be appreciated that in some variations wherethe outer diameter of the first segment (506) tapers from a firstdiameter at a proximal end of the first segment (506) and a seconddiameter at a distal end of the first segment (506), the second diameterof the first segment (506) may be equal to the outer diameter of thesecond segment (508). For example, in variations where the outerdiameter of the first segment (506) is tapered from a first diameter ata proximal end of the first segment (506) to about 8 mm at the distalend of the first segment (506), the second segment (508) may have anouter diameter of about 8 mm.

As a portion of implant is moved into the second segment (508) of thecrimping chamber, the outer diameter of that portion of the implant maybe crimped to the outer diameter of the second segment (508) to allowthat portion of the implant to fit within the second segment (508), aswill be discussed in more detail below. As mentioned above, in somevariations, the second segment (508) may not have any ribs (516)positioned therein. In variations that do include a plurality of ribs(516) defining a plurality of channels (518), the legs of the implantsmay be at least partially housed in the plurality of channels (518) asthe implant is advanced into the second segment (508). As discussedabove with respect to the first segment (506), in some variations, eachleg may be positioned in a separate channel (518) of the second segment(508). In these variations, second segment (508) of the crimping chamber(504) may have at least as many channels (518) as legs of the implant.In other variations, multiple legs (e.g., two, three, or more legs) maybe positioned in individual channels (518) of the second segment (508).In these variations, the second segment (508) may have fewer channels(518) than the number of legs of the implant. While the second segment(508) is shown in FIGS. 5A-5D as having eight ribs (516) defining eightchannels (518), it should be appreciated that the second segment (508)may include any suitable number of ribs and channels (e.g., two, three,four, five, six, or seven or more ribs and channels), which may or maynot be the same number of ribs and channels as the first segment (invariations where the first segment comprises a plurality of ribs and aplurality of channels). In instances where a plurality of ribs (516) andplurality of channels (518) extend from the first segment (506) into thesecond segment (508), the ribs (516) and channels (518) may helpmaintain alignment of the implant relative to the crimping chamber (504)as the implant is moved from the first segment (506) to the secondsegment (508), as will be discussed in more detail below.

Additionally, in some variations, the second segment (508) of thecrimping chamber may be sized to receive an outer sheath of a deliverydevice (e.g., the outer sheath (206) of the delivery device (200)described above with respect to FIGS. 3A and 3B above) therein. In thesevariations, the inner diameter of the second segment (508) may begreater than or equal to the outer diameter of a distal portion of theouter sheath of the delivery device. For example, in variations wherethe outer sheath of a delivery device has a diameter of about 6 mm, theinner diameter of the second segment (508) may be at least about 6 mm(e.g., about 6 mm). In some variations, the second segment (508) mayhave an inner diameter of about 6 mm and an outer diameter of about 8mm. The outer sheath may be inserted into the second segment (508)during crimping to hold the implant in a low profile configuration, aswill be discussed in more detail below. It should be appreciated thatwhile the second segment (508) is shown in FIGS. 5A and 5B as havinguniform inner and outer diameters, in some instances the inner diameter,the outer diameter, or both the inner and outer diameters may be taperedalong a length of the second segment.

The third segment (510) may be configured to receive a portion of theimplant as the implant is moved from the second segment (508). In somevariations, such as shown in FIGS. 5A-5D, the outer diameter of thethird segment (510) may be equal to the outer diameter of the secondsegment (508) (e.g., in some variations where the second segment (508)has an outer diameter of about 8 mm, the third segment (510) may have anouter diameter of about 8 mm). In other variations, the outer diameterof the third segment (510) may be smaller than the outer diameter of thesecond segment (508). In these variations, the implant may be furthercrimped as a portion of the implant moves from the second segment (508)to the third segment (510) (e.g., the outer diameter of that portion ofthe device may be crimped to the outer diameter of the third segment(510) which may allow that portion of the implant to fit within thethird segment (510)).

In variations where the second segment (508) is sized to receive anouter sheath of a delivery device (e.g., where the second segment (508)has an inner diameter greater than an outer diameter of the outersheath), the third segment (510) may be sized to prevent the outersheath from being advanced from the second segment (508) into the thirdsegment (510). In some of these variations, the inner diameter of thethird segment (510) may be smaller than an outer diameter of the outersheath of the delivery device. For example, in instances where the outersheath of the delivery device has an outer diameter or about 6 mm, theinner diameter of the third segment (510) may be less than about 6 mm(e.g., about 3.5 mm, between about 3.5 mm and about 4 mm). In variationswhere the third segment (510) comprises a plurality of ribs (516), theplurality of ribs (516) may define the inner diameter such that theouter sheath of the delivery device catches on or otherwise engages theribs (516) of the third segment (510) during advancement of the outersheath, which may prevent the outer sheath from being advanced into thethird segment (510), as discussed in more detail below.

In variations where the crimping device (500) is used to crimp animplant having a hub and a plurality of legs extending from the hub, thethird segment (510) may be configured to accommodate the hub of theimplant. For example, the inner diameter of the third segment (510) maybe greater than or equal to the outer diameter of the hub. In variationswhere the hub of the implant has an outer diameter of about 3.5 mm, theinner diameter of the third segment (510) may be at least about 3.5 mm(e.g., about 3.5 mm). In some instances, it may be desirable to size theinner diameter of the third segment (510) to be equal to or slightlylarger (e.g., less than 1 mm larger) than the outer diameter, which mayhelp to center the hub within the inner diameter of the third segment(510) during advancement of the implant. In some variations, the innerdiameter of the third segment (510) may greater than or equal to anouter diameter of a hub of the implant and may be less than the outerdiameter of an outer sheath of a delivery device.

In some variations, the height of the third segment (510) may be sizedsuch only a portion of the implant may be received in the third segment(510). For example, in these variations the height of the third segment(510) may be less than the height of the implant when the implant iscrimped. Accordingly, when the implant is advanced into the thirdsegment (510) at least a portion of the implant (e.g., a proximalportion of the legs of the implant) may extend out of the third segment(510) (e.g., into the second segment (508)). In variations where theinner diameter of the third segment (510) is smaller than the outerdiameter of an outer sheath (e.g., which may prevent the outer sheathfrom entering the third segment (510)), the height of the third segment(510) may facilitate placement of the outer sheath of the deliverydevice at a predetermined position along the implant.

As mentioned above, in some variations the third segment (510) mayinclude a plurality of ribs (516) positioned therein and defining aplurality of channels (518). In these variations, the legs of theimplants may be at least partially housed in the plurality of channels(518) as the implant is advanced into the third segment (510). Asdiscussed above with respect to the second segment (508), in somevariations, each leg may be positioned in a separate channel (518) ofthe third segment (510). In these variations, third segment (510) of thecrimping chamber (504) may have at least as many channels (518) as legsof the implant. In other variations, multiple legs (e.g., two, three, ormore legs) may be positioned in individual channels (518) of the thirdsegment (510). In these variations, the third segment (508) may havefewer channels (518) than the number of legs of the implant. While thethird segment (510) is shown in FIGS. 5A-5D as having eight ribs (516)defining eight channels (518), it should be appreciated that the thirdsegment (510) may include any suitable number of ribs and channels(e.g., two, three, four, five, six, or seven or more ribs and channels).

In variations where the second segment comprises a plurality of ribs(516) positioned therein, some or all of the ribs (516) of the secondsegment (508) may extend from the second segment (508) into the thirdsegment (510), the ribs (516) and channels (518) may help maintainalignment of the implant relative to the crimping chamber (504) as theimplant is advanced into the third segment (510). In some of thesevariations, the number of ribs and channels in the third segment (510)may be equal to the number of ribs and channels in the second segment(508), although it should be appreciated that in some instances thethird segment (510) may have more or fewer ribs and channels than thesecond segment (508). As mentioned above, the inner diameter of thesecond segment (508) may be larger than the inner diameter of the thirdsegment (510), while the outer diameter of the second segment (508) maybe the same as the outer diameter of the third segment (510). In some ofthese variations, each of the second and third segments may comprise aplurality of ribs defining a plurality of channels, and the channels(518) may in the second segment (508) may be shallower than the channels(518) in the third segment (510).

In some variations, such as the variation shown in FIGS. 5A-5D, thehousing may further comprise a base (522). The base may be integrallyformed with the housing (502), as shown in FIGS. 5A and 5C-5D, or it maybe attached to the housing (502). The base (522) may be located at thedistal end of the housing (502), near the distal end of the thirdsegment (510) of the crimping chamber (504). In some variations, thebase (522) may have a larger diameter than the housing (502) surroundingthe third segment (508), and may provide a surface on which the crimpingdevice (500) may be rested. Additionally or alternatively, the base(522) may provide stability during crimping when a delivery device andimplant are pressed distally into the crimping chamber (504), asdescribed in more detail below.

FIGS. 6A-6C depict a method by which the crimping device (500) may beused to crimp the implant (100) described above with respect to FIGS. 1and 2A-2F from an expanded configuration to a low-profile configuration.It should be appreciated, however, that the crimping device (500) may beused to crimp any suitable implant. As shown in FIG. 6A, the implant(100) may first be placed in the first segment (506) of the crimpingchamber (504). To place the implant (100) in the first segment (506),the implant (100) may be advanced through the proximal opening (512) ofthe crimping chamber (504). In some variations, the implant (100) may betemporarily moved toward a low-profile configuration (e.g., bytemporarily flexing the legs (103) of the implant toward thelongitudinal axis of the implant (100)) to allow the implant to enterthe crimping chamber (504) through the proximal opening (512). Invariations in which the crimping device (500) comprise a removable cap,the cap may be removed from the housing (502) to temporarily increasethe size of the proximal opening (512). In some of these variations, theimplant (100) may be inserted into the first segment (506) in anexpanded (e.g., uncrimped) configuration, and the cap may then bereplaced onto the proximal end of the housing (502). Generally, the lip(520) may hold the implant (100) in the crimping chamber (504) until theimplant (100) is crimped to a low-profile configuration.

When the implant (100) is placed in the first segment (506) of thecrimping chamber (504), the hub (102) of the implant (100) may belocated distally relative to the legs (103) (i.e., toward the thirdsegment (510)). One or more portions of the legs (103) (e.g., theproximal ends of the legs) may rest on the inner surface of the housing(502) within the first segment (506) when the implant (100) ispositioned in the first segment (506), such as shown in FIG. 6A. In somevariations, a portion of each leg (103) may be positioned at leastpartially in a channel (518) of the plurality of channels (518). Inother variations (e.g., in variations where some or all of the firstsegment (506) does not include ribs (516) and channels (518)), theimplant (100) may be positioned in the first segment (506) such that thelegs (103) may rest against a portion of the first segment (506) thatdoes not include ribs (516) and channels (518). For example, in somevariations, the proximal ends of the legs (103) may rest against a wallof the housing (502) proximally of the plurality of ribs (516) andplurality of channels (518).

With the implant (100) positioned in the first segment (506), thedelivery device (200) described above with respect to FIGS. 1, 3A, and3B may be used to advance a portion of the implant (100) into the secondsegment (502). It should be appreciated that the crimping device (500)may be used in conjunction with any suitable delivery device, or may beoperated independently of a delivery device. As shown in FIGS. 6A and6B, a portion of the delivery device (200) may engage a portion of theimplant (100) to advance the implant (100). For example, a distal tip ofthe inner shaft (204) (e.g., the ball tip (207)) may be placed intocontact with a hub (102) (e.g., the proximal end of the hub (102)). Theinner shaft (204) may be delivery device (200) may be advanced towardthe second segment (508) to push the implant (100) toward the secondsegment (508) of the crimping chamber (504). As the hub (102) isadvanced into the second segment (508), the legs (103) of the implantmay be rotated toward the longitudinal axis of the implant (100) to movethe implant toward the low-profile configuration. Specifically, as theportions of the legs (103) in contact with the outer diameter (only theinner diameters of the first, second, and third segments are illustratedin FIGS. 6A-6C) of the first segment (506) are moved toward the secondsegment (508), the tapering outer diameter of the first segment (506)may apply a radial force to push against the legs (103) to rotate thelegs (103) toward the longitudinal axis of the implant (100). Invariations where the first segment (506) includes a plurality of ribs(516) defining a plurality of channels (518), a portion of each of thelegs (103) may be positioned in one of the channels (518). This maylimit rotation of the implant (100) around the longitudinal axis of theimplant (100), and may help to keep the implant (100) centered orotherwise aligned with the crimping device (500) during advancement ofthe implant (100). For example, positioning a portion of the legs (103)within the channels (518) may reduce the likelihood that the implant(100) will shift relative to the crimping device (500) duringadvancement and crimping of the implant (100). As mentioned above, insome of these variations, each leg (103) of the implant (100) may bepositioned in a different channel (518), while in other variations,multiple legs (103) may be positioned in individual channels (518).

As portions of the legs (103) enter the second segment (508), the outerdiameter of that portion of the implant (100) may be limited by theouter diameter of the second segment (508). In variations where thesecond segment (508) includes a plurality of ribs (516) defining aplurality of channels (518), a portion of each of the legs (103) may bepositioned in one of the channels (518) (e.g., each leg (103) of theimplant (100) may be positioned in a different channel (518) or multiplelegs (103) may be positioned in individual channels (518)), which mayhelp guide and align the implant (100).

Further advancement of the inner shaft (204) toward the third segment(510) may advance the hub (102) of the implant into the third segment(510), such as shown in FIG. 6B. In some variations, the third segment(510) may be sized such that at least a portion of some or all of thelegs (103) remain in the second segment (508) when the hub (102) isadvanced into the third segment (510). Additionally or alternatively, invariations where the third segment (510) has a smaller outer diameterthan the outer diameter of the second segment (508), advancement of aportion of the legs (103) into the third segment (510) may further crimpthe implant (100). In variations where the third segment (508) includesa plurality of ribs (516) defining a plurality of channels (518), aportion of each of the legs (103) may be positioned in one of thechannels (518) (e.g., each leg (103) of the implant (100) may bepositioned in a different channel (518) or multiple legs (103) may bepositioned in individual channels (518)), which may help guide and alignthe implant (100). In variations where the plurality of ribs (516) andchannels (518) extend from the first segment (506) to the third segment(510), each leg (103) may be advanced along the same channel (518)during advancement along the first, second, and third segments. In somevariations, when the delivery device (200) and implant (100) are fullyadvanced into the crimping chamber (504), as shown in FIG. 6B, thedistal end of the hub (102) of the implant (100) may pressed against thedistal end (514) of the crimping chamber (504).

In variations where the delivery device (200) comprises and outer sheath(206), the inner shaft (204) may advance the hub (102) into the thirdsegment (as discussed immediately above) with the outer sheath (206)retracted relative to the inner shaft (204). As the delivery device(200) and implant (100) are pushed toward the third segment (510), thelegs (103) of the implant (100) may rotate relative to the hub (102)toward a low-profile (i.e., crimped) configuration, which in someinstances may position a portion of each of the legs (103) into contactwith or substantially parallel to the inner shaft (204) of the deliverydevice (200) (e.g., in some instances the legs may contact an engagementsleeve of the inner shaft). With the implant (100) positioned in alow-profile configuration, the outer sheath (206) may be advancedrelative to the inner shaft (204) to cover at least a portion of thelegs (103) with a portion of the outer sheath (206) (e.g., the distalcup (210) of the outer sheath (206)). This may act to hold the legs(103) of the implant (100) between the distal cup (210) and the innershaft (204) of the delivery device (200), and thus may couple theimplant (100) thereto, such as shown in FIG. 6C. In variations where theinner diameter of the third segment (510) is less than an outer diameterof the distal end of the outer sheath (e.g., the distal end of thedistal cup (210)), the outer cup (210) may be prevented from enteringthe third segment (510). In some of these variations, the outer sheath(206) may be advanced until a distal end of the outer sheath (206)(e.g., the distal end of the outer cup (210)) contacts the ribs (516) ofthe third segment (510), such as shown in FIG. 6C.

With the delivery device (200) coupled to the implant (100), thedelivery device (200) and implant (100) may be withdrawn relative to thecrimping device (500). The delivery device (200) may then be used todeliver the implant (100) to a target location within a patient's body.To deliver the implant (100), the outer sheath (206) may be withdrawn(e.g., by retracting the outer sheath (206) relative to the inner shaft(204)) to expose the legs (103) of the implant. The implant (100) maythen be expanded (either by self-expansion or via a device such as aballoon) in the patient to press against, dilate, or otherwise holdtissue in the patient.

The implants described here may be delivered to any suitable portion ofthe anatomy in any suitable manner. In some variations, the implant maybe delivered to a sinus cavity or sinus ostium. In other variations, theimplant may be delivered to a nasal cavity. In some variations, theimplant may deliver, elute, or otherwise release one or more drugstherefrom when implanted.

The implants may be delivered and deployed in any suitable manner. Insome variations, the implants are deployed in an open surgical fashion.In other variations, the implants are deployed in a less invasivefashion (for example, laparoscopically, endoscopically, orintravascularly through the use of catheters). In instances where theimplants are delivered in a generally minimally invasive fashion, theimplants may be delivered in their low-profile configurations. Theimplants may be preloaded in or on a delivery device, but need not be.For example, in instances where the implant has a limited ability tofully expand after remaining in its compressed state for extendedperiods of time (i.e., relaxation of the implant may occur over time,resulting in a loss of shape memory, for example), it may be moredesirable to crimp and load the implant into or onto a delivery devicejust prior to delivery and deployment.

Generally, at least a portion of a delivery device is introduced intothe body. In some variations, the delivery device may be introduced intoa natural opening in the body, such as an ear canal or a nostril. Inother variations, the delivery device may be introduced into an openingin formed in the body via one or more procedures (e.g., asurgically-formed opening). In some of these variations, theartificially-created opening may be pre-formed using one or more toolsthat are separate from the delivery device. In some variations, one ormore portions of the delivery device may be used to create the opening.In still other variations, one or more portions of the expandable devicemay be used to create the opening.

Once the delivery device is introduced into the body, at least a portionof the delivery device may then be advanced to a target location. Insome variations, this advancement occurs under direct visualization. Thedirect visualization may be achieved by a device external to thedelivery device, such as an endoscope, or may be achieved by one or morevisualization devices attached to the delivery device or disposed withinone or more portions (i.e., a lumen of a cannula) of the deliverydevice. In other variations, the advancement occurs under indirectvisualization, such as fluoroscopy, ultrasound, or computer imageguidance.

Once the delivery device is introduced into the body, at least a portionof the delivery device may then be advanced to a target location. Insome variations, this advancement occurs under direct visualization. Thedirect visualization may be achieved by a device external to thedelivery device, such as an endoscope, or may be achieved by one or morevisualization devices attached to the delivery device or disposed withinone or more portions (i.e., a lumen of a cannula) of the deliverydevice. In other variations, the advancement occurs under indirectvisualization, such as fluoroscopy, ultrasound, or computer imageguidance.

Once the delivery device has reached the target location, the expandableimplant may be released from the delivery device. In variations wherethe implant is self-expandable, the implant may self-expand into anexpanded configuration. In variations where the implant is expandable inresponse to one or more forces or stimuli, one or more appropriateforces or stimuli may be applied to the implant to expand the implantinto an expanded configuration. In some instances, expansion of theimplant may act to anchor the implant against or into tissue. Theimplant may be left in place for any suitable amount of time (e.g., oneweek, two weeks, one month, two months, or more). In variations wherethe implant is biodegradable, the implant may be removed prior tocomplete degradation of the implant, or may be left in place until theimplant is absorbed or otherwise cleared by the body. When the implantis removed, it may be removed using a grasping device, pull-stringstructure, or the like.

When used to treat nasal polyposis or other polypoid edema one or moreof the implant described here may be delivered into either a nasalpassage or one or more sinus cavities. Once expanded, each leg of theimplant may either sit against one or more nasal polyps, puncture one ormore nasal polyps, push between two or more nasal polyps to contact thebase of one or more nasal polyps, or do a combination thereof. When theimplant is configured to deliver one or more drugs, it may be especiallybeneficial to deliver one or more drugs to the base of one or more ofthe nasal polyps. When one or more legs presses against one or morenasal polyps, the one or more legs may dilate or otherwise move thenasal polyps. This may, in turn, open one or more blocked nasalpassageways or sinus ostia. It should be appreciated that the implantsdescribed here may be delivered using any of the methods described inU.S. patent application Ser. No. 12/779,240, which was previouslyincorporated by reference.

Although the foregoing invention has, for the purposes of clarity andunderstanding been described in some detail by way of illustration andexample, it will be apparent that certain changes and modifications maybe practiced, and are intended to fall within the scope of the appendedclaims.

I claim:
 1. A device for crimping an implant, the device comprising ahousing configured to receive the implant, the housing having proximalopening, a tapered first segment, a second segment, a distal thirdsegment, and a plurality of channels radially extending from the thirdsegment and at least partially along the first segment, wherein theimplant has a hub and a plurality of legs extending from the hub, andwherein movement of the hub into the third segment radially compressesthe legs toward a longitudinal axis of the implant to configure theimplant into a low-profile configuration, wherein the hub includes aplurality of apertures extending through the hub, and wherein theplurality of legs includes a plurality of filaments each positioned in acorresponding aperture of the plurality of apertures to extend throughthe hub to define a first leg on a first side of the hub and a secondleg on a second side of the hub.
 2. The device of claim 1, wherein thetapered first segment has a diameter of from about 6-8 mm at a distalend of the first segment adjacent to the second segment and a diameterof from about 25-30 mm at a proximal end of the first segment adjacentto the proximal opening.
 3. The device of claim 1, wherein secondsegment has a diameter of about 6 mm.
 4. The device of claim 1, whereindistal third segment has a diameter that is from about equal to an outerdiameter of the hub to less than 1 mm larger than the outer diameter ofthe hub.
 5. The device of claim 1, wherein the plurality of channelsradially extend from the third segment along the second segment and atleast partially along the first segment.
 6. The device of claim 1,wherein the housing further comprises a plurality of ribs radiallyextending from the third segment and at least partially along the firstsegment.
 7. The device of claim 6, wherein the plurality of ribsradially extend from the third segment along the second segment and atleast partially along the first segment.
 8. The device of claim 6,wherein the plurality of ribs defines the plurality of channels.
 9. Thedevice of claim 1, wherein each leg is positioned in a separate channel.10. The device of claim 1, wherein two or more legs are positioned in achannel.
 11. The device of claim 1, wherein the housing is formed from apolycarbonate, polypropylene, or a polyurethane.
 12. The device of claim1, further comprising a cap fit around the perimeter of the proximalopening.
 13. The device of claim 1, wherein movement of the hub into arecess defined in the third segment rotates the plurality of legs towarda longitudinal axis of the implant to move the implant to a low-profileconfiguration.
 14. The device of claim 13, further comprising: acrimping member, wherein the crimping member comprises a plurality ofarms radially extending from a stem portion, wherein the stem portioncomprises a recess configured to receive a portion of the implant, andwherein each arm of the plurality of arms is at least partiallypositioned within a corresponding channel of the plurality of channels;and a spring positioned between the stem portion and the third segment,wherein movement of the stem portion into the third segment rotates theplurality of arms relative to the stem portion.
 15. A method forcrimping an implant using a crimping device, the implant comprising adistal hub and a plurality of legs extending in a proximal directionfrom the hub, the crimping device comprising a housing, the housingcomprising a distal recess and a plurality of channels radiallyextending in a proximal direction from the recess, the method comprisingadvancing the hub in a distal direction into the recess, and radiallycompressing the plurality of legs of the implant toward a longitudinalaxis of the implant to move the implant to a low-profile configuration.16. The method of claim 15, wherein the crimping device furthercomprises a plurality of ribs defining the plurality of channels,wherein one or more of the plurality of legs is positioned in at leastone of the channels.
 17. The method of claim 15, further comprisingengaging the hub of the implant with a delivery device, advancing thehub in the distal direction by exerting force with the delivery deviceon the implant in the distal direction, and once the legs of the implantare in a low-profile configuration, extending a sheath in a distaldirection around the legs of the implant, wherein the sheath ismechanically coupled to the delivery device.
 18. The method of claim 17,further comprising withdrawing the delivery device from the crimpingdevice, the delivery device holding the implant in the low-profileconfiguration with the sheath at least partially around the legs of theimplant.
 19. The method of claim 15, wherein radially compressing theplurality of legs of the implant further comprises rotating theplurality of legs toward a longitudinal axis of the implant to move theimplant to a low-profile configuration.
 20. A device for crimping animplant, the device comprising: a housing configured to receive theimplant, the housing including: a proximal opening; a tapered firstsegment; a second segment; a distal third segment; and a plurality ofchannels radially extending from the third segment and at leastpartially along the first segment, wherein the implant includes a huband a plurality of legs extending from the hub, and wherein movement ofthe hub into the third segment radially compresses the legs toward alongitudinal axis of the implant to configure the implant into alow-profile configuration, and wherein the tapered first segment has adiameter of from about 6-8 mm at a distal end of the first segmentadjacent to the second segment and a diameter of from about 25-30 mm ata proximal end of the first segment adjacent to the proximal opening.21. A device for crimping an implant, the device comprising: a housingconfigured to receive the implant, the housing including: a proximalopening; a tapered first segment; a second segment; a distal thirdsegment; and a plurality of channels radially extending from the thirdsegment and at least partially along the first segment, wherein theimplant includes a hub and a plurality of legs extending from the hub,and wherein movement of the hub into the third segment radiallycompresses the legs toward a longitudinal axis of the implant toconfigure the implant into a low-profile configuration, and whereindistal third segment has a diameter that is from about equal to an outerdiameter of the hub to less than 1 mm larger than the outer diameter ofthe hub.
 22. A device for crimping an implant, the device comprising: ahousing configured to receive the implant, the housing including: aproximal opening; a tapered first segment; a second segment; a distalthird segment; and a plurality of channels radially extending from thethird segment and at least partially along the first segment, whereinthe implant includes a hub and a plurality of legs extending from thehub, and wherein movement of the hub into the third segment radiallycompresses the legs toward a longitudinal axis of the implant toconfigure the implant into a low-profile configuration; and a cap fitaround the perimeter of the proximal opening.